ID

44546

Description

Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01935700

Link

https://clinicaltrials.gov/show/NCT01935700

Keywords

Versions (2)
  1. 2/23/20 2/23/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT01935700

    English

    Eligibility Hepatocellular Carcinoma NCT01935700

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. . patient has at least one of the following criteria: (1) positive for hepatocellular carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400 ng/ml and has evidence of hepatocellular carcinoma provided by contrast-enhanced computed tomography or magnetic resonance imaging.
    Description

    Liver carcinoma Positive Cytology | Liver carcinoma Positive Pathology | Alpha one fetoprotein measurement | Liver carcinoma CT scan contrast | Liver carcinoma Magnetic Resonance Imaging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2239176
    UMLS CUI [1,2]
    C1514241
    UMLS CUI [1,3]
    C1305671
    UMLS CUI [2,1]
    C2239176
    UMLS CUI [2,2]
    C1514241
    UMLS CUI [2,3]
    C0919386
    UMLS CUI [3]
    C0201539
    UMLS CUI [4,1]
    C2239176
    UMLS CUI [4,2]
    C0742919
    UMLS CUI [5,1]
    C2239176
    UMLS CUI [5,2]
    C0024485
    2. . contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
    Description

    CT scan contrast | Magnetic Resonance Imaging | Distant metastasis caused by Liver carcinoma | Large vessel Invasion caused by Liver carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0742919
    UMLS CUI [2]
    C0024485
    UMLS CUI [3,1]
    C1269798
    UMLS CUI [3,2]
    C0015127
    UMLS CUI [3,3]
    C2239176
    UMLS CUI [4,1]
    C0225990
    UMLS CUI [4,2]
    C1269955
    UMLS CUI [4,3]
    C0015127
    UMLS CUI [4,4]
    C2239176
    3. . patient has child a hepatic reserved function
    Description

    Liver function Child-Pugh Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C4050412
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. . there are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
    Description

    Hemorrhage Life Threatening | Gastrointestinal Hemorrhage | Hemorrhage Organ Vital | Pulmonary hemorrhage | Brain hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C2826244
    UMLS CUI [2]
    C0017181
    UMLS CUI [3,1]
    C0019080
    UMLS CUI [3,2]
    C0178784
    UMLS CUI [3,3]
    C0442732
    UMLS CUI [4]
    C0151701
    UMLS CUI [5]
    C0553692
    2. . there are life-threatening bacterial, fungal or viral infection (not included hepatitis b and c virus).
    Description

    Bacterial Infection Life Threatening | Mycoses Life Threatening | Virus Disease Life Threatening | Exception Hepatitis B | Exception Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004623
    UMLS CUI [1,2]
    C2826244
    UMLS CUI [2,1]
    C0026946
    UMLS CUI [2,2]
    C2826244
    UMLS CUI [3,1]
    C0042769
    UMLS CUI [3,2]
    C2826244
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0019163
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0019196
    3. . patient has serum creatinine level > 1.5 mg/dl.
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    4. . patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
    Description

    Statins Long-term | Fibrates Long-term | Statins Change Unsuccessful | Fibrates Change Unsuccessful

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0360714
    UMLS CUI [1,2]
    C0443252
    UMLS CUI [2,1]
    C1449704
    UMLS CUI [2,2]
    C0443252
    UMLS CUI [3,1]
    C0360714
    UMLS CUI [3,2]
    C0392747
    UMLS CUI [3,3]
    C1272705
    UMLS CUI [4,1]
    C1449704
    UMLS CUI [4,2]
    C0392747
    UMLS CUI [4,3]
    C1272705
    5. . patient has white blood cell count < 1500/µl, platelet count < 30000/µl or hemoglobin < 9.0 gm/dl after medication.
    Description

    White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Status post Pharmaceutical Preparations

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0518015
    UMLS CUI [4,1]
    C0231290
    UMLS CUI [4,2]
    C0013227
    6. . pregnant woman or plan to be a pregnant woman
    Description

    Pregnancy | Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0032992
    7. . allergy to colchicine or has history of severe side effects caused by colchicine
    Description

    Colchicine allergy | Side effects caused by Colchicine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0571131
    UMLS CUI [2,1]
    C0879626
    UMLS CUI [2,2]
    C0015127
    UMLS CUI [2,3]
    C0009262
    8. . patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
    Description

    Systemic Chemotherapy | Systemic Chemotherapy Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1883256
    UMLS CUI [2,1]
    C1883256
    UMLS CUI [2,2]
    C1301732
    9. . patient is under or plans to receive nexavar or other clinical trial testing drug.
    Description

    Nexavar | Nexavar Planned | Investigational New Drugs Other | Investigational New Drugs Other Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1677799
    UMLS CUI [2,1]
    C1677799
    UMLS CUI [2,2]
    C1301732
    UMLS CUI [3,1]
    C0013230
    UMLS CUI [3,2]
    C0205394
    UMLS CUI [4,1]
    C0013230
    UMLS CUI [4,2]
    C0205394
    UMLS CUI [4,3]
    C1301732
    10. . patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
    Description

    Malfunction Organ Vital | Study Subject Participation Status Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231174
    UMLS CUI [1,2]
    C0178784
    UMLS CUI [1,3]
    C0442732
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0332196
    11. . patient is under or plans to receive chinese traditional medicine or herb drugs.
    Description

    Traditional Chinese Medicine Formulation | Traditional Chinese Medicine Formulation Planned | Chinese herbal medicine | Chinese herbal medicine Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4331423
    UMLS CUI [2,1]
    C4331423
    UMLS CUI [2,2]
    C1301732
    UMLS CUI [3]
    C1273412
    UMLS CUI [4,1]
    C1273412
    UMLS CUI [4,2]
    C1301732
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    Similar models

    Eligibility Hepatocellular Carcinoma NCT01935700

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Liver carcinoma Positive Cytology | Liver carcinoma Positive Pathology | Alpha one fetoprotein measurement | Liver carcinoma CT scan contrast | Liver carcinoma Magnetic Resonance Imaging
    Item
    1. . patient has at least one of the following criteria: (1) positive for hepatocellular carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400 ng/ml and has evidence of hepatocellular carcinoma provided by contrast-enhanced computed tomography or magnetic resonance imaging.
    boolean
    C2239176 (UMLS CUI [1,1])
    C1514241 (UMLS CUI [1,2])
    C1305671 (UMLS CUI [1,3])
    C2239176 (UMLS CUI [2,1])
    C1514241 (UMLS CUI [2,2])
    C0919386 (UMLS CUI [2,3])
    C0201539 (UMLS CUI [3])
    C2239176 (UMLS CUI [4,1])
    C0742919 (UMLS CUI [4,2])
    C2239176 (UMLS CUI [5,1])
    C0024485 (UMLS CUI [5,2])
    CT scan contrast | Magnetic Resonance Imaging | Distant metastasis caused by Liver carcinoma | Large vessel Invasion caused by Liver carcinoma
    Item
    2. . contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
    boolean
    C0742919 (UMLS CUI [1])
    C0024485 (UMLS CUI [2])
    C1269798 (UMLS CUI [3,1])
    C0015127 (UMLS CUI [3,2])
    C2239176 (UMLS CUI [3,3])
    C0225990 (UMLS CUI [4,1])
    C1269955 (UMLS CUI [4,2])
    C0015127 (UMLS CUI [4,3])
    C2239176 (UMLS CUI [4,4])
    Liver function Child-Pugh Classification
    Item
    3. . patient has child a hepatic reserved function
    boolean
    C0232741 (UMLS CUI [1,1])
    C4050412 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Hemorrhage Life Threatening | Gastrointestinal Hemorrhage | Hemorrhage Organ Vital | Pulmonary hemorrhage | Brain hemorrhage
    Item
    1. . there are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
    boolean
    C0019080 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    C0017181 (UMLS CUI [2])
    C0019080 (UMLS CUI [3,1])
    C0178784 (UMLS CUI [3,2])
    C0442732 (UMLS CUI [3,3])
    C0151701 (UMLS CUI [4])
    C0553692 (UMLS CUI [5])
    Bacterial Infection Life Threatening | Mycoses Life Threatening | Virus Disease Life Threatening | Exception Hepatitis B | Exception Hepatitis C
    Item
    2. . there are life-threatening bacterial, fungal or viral infection (not included hepatitis b and c virus).
    boolean
    C0004623 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    C0026946 (UMLS CUI [2,1])
    C2826244 (UMLS CUI [2,2])
    C0042769 (UMLS CUI [3,1])
    C2826244 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0019163 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0019196 (UMLS CUI [5,2])
    Creatinine measurement, serum
    Item
    3. . patient has serum creatinine level > 1.5 mg/dl.
    boolean
    C0201976 (UMLS CUI [1])
    Statins Long-term | Fibrates Long-term | Statins Change Unsuccessful | Fibrates Change Unsuccessful
    Item
    4. . patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
    boolean
    C0360714 (UMLS CUI [1,1])
    C0443252 (UMLS CUI [1,2])
    C1449704 (UMLS CUI [2,1])
    C0443252 (UMLS CUI [2,2])
    C0360714 (UMLS CUI [3,1])
    C0392747 (UMLS CUI [3,2])
    C1272705 (UMLS CUI [3,3])
    C1449704 (UMLS CUI [4,1])
    C0392747 (UMLS CUI [4,2])
    C1272705 (UMLS CUI [4,3])
    White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Status post Pharmaceutical Preparations
    Item
    5. . patient has white blood cell count < 1500/µl, platelet count < 30000/µl or hemoglobin < 9.0 gm/dl after medication.
    boolean
    C0023508 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0518015 (UMLS CUI [3])
    C0231290 (UMLS CUI [4,1])
    C0013227 (UMLS CUI [4,2])
    Pregnancy | Pregnancy, Planned
    Item
    6. . pregnant woman or plan to be a pregnant woman
    boolean
    C0032961 (UMLS CUI [1])
    C0032992 (UMLS CUI [2])
    Colchicine allergy | Side effects caused by Colchicine
    Item
    7. . allergy to colchicine or has history of severe side effects caused by colchicine
    boolean
    C0571131 (UMLS CUI [1])
    C0879626 (UMLS CUI [2,1])
    C0015127 (UMLS CUI [2,2])
    C0009262 (UMLS CUI [2,3])
    Systemic Chemotherapy | Systemic Chemotherapy Planned
    Item
    8. . patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
    boolean
    C1883256 (UMLS CUI [1])
    C1883256 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    Nexavar | Nexavar Planned | Investigational New Drugs Other | Investigational New Drugs Other Planned
    Item
    9. . patient is under or plans to receive nexavar or other clinical trial testing drug.
    boolean
    C1677799 (UMLS CUI [1])
    C1677799 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    C0013230 (UMLS CUI [3,1])
    C0205394 (UMLS CUI [3,2])
    C0013230 (UMLS CUI [4,1])
    C0205394 (UMLS CUI [4,2])
    C1301732 (UMLS CUI [4,3])
    Malfunction Organ Vital | Study Subject Participation Status Excluded
    Item
    10. . patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
    boolean
    C0231174 (UMLS CUI [1,1])
    C0178784 (UMLS CUI [1,2])
    C0442732 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    Traditional Chinese Medicine Formulation | Traditional Chinese Medicine Formulation Planned | Chinese herbal medicine | Chinese herbal medicine Planned
    Item
    11. . patient is under or plans to receive chinese traditional medicine or herb drugs.
    boolean
    C4331423 (UMLS CUI [1])
    C4331423 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    C1273412 (UMLS CUI [3])
    C1273412 (UMLS CUI [4,1])
    C1301732 (UMLS CUI [4,2])
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